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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998
Reference Type:
other: Amendment
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1-Butanaminium, N ,N-dibutyl-N-methyl-, methyl sulfate
- Physical state: solid (congealed melt), white
- Storage condition of test material: room temperature
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 601

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Weight at study initiation: 3.67, 3.46 and 3.44 kg
- Housing: individually in stainless steel wire mesh cages with grating floor area: 3000 cm2. No bedding in the cages; sawdust in the waste trays.
- Diet: Kliba-Labordiet, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 mL tap water per animal per day
- Acclimation period: for at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL of the at about 80°C heated test substance. Before application it was cooled down to body temperature.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
15 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the substance was washed out with tap water
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to OECD guideline 405 and EEC L 383a, b.5 (dec. 29, 1992)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Other effects:
Suppuration was seen on day 8 in animal no. 1.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Executive summary:

In an OECD TG 405 study (performed in compliance with GLP), the potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed in 3 white New Zealand rabbits, subjected to a single ocular application of 0.1 mL of the test substance on day 0. The average score (24 to 72 hours) for irritation was calculated to be 0 for corneal opacity for all animals. One animal had an iris score of 0.7, while no iris effects were observed in the other two animals. The conjunctivae redness scores were 2.7, 2.7, and 2.3 for the three animals, respectively. The chemosis scores were 1.3, 0.3, and 2, respectively. The findings were reversible in all animals within 15 days after application; thus the study was terminated. Considering the described findings the test substance gives indication of an irritant property to the eye.